The effect of fish oil on the immune system and red blood cell function of patients around surgery.
- Conditions
- Patients undergoing colon surgery for malignancy.MedDRA version: 17.0Level: LLTClassification code 10009951Term: Colon cancer NOSSystem Organ Class: 100000004864MedDRA version: 17.0Level: LLTClassification code 10009950Term: Colon cancer Duke's DSystem Organ Class: 100000004864MedDRA version: 17.0Level: LLTClassification code 10009946Term: Colon cancer Duke's ASystem Organ Class: 100000004864MedDRA version: 17.0Level: LLTClassification code 10009947Term: Colon cancer Duke's B1System Organ Class: 100000004864MedDRA version: 17.0Level: LLTClassification code 10009948Term: Colon cancer Duke's B2System Organ Class: 100000004864MedDRA version: 17.0Level: LLTClassification code 10009949Term: Colon cancer Duke's CSystem Organ Class: 100000004864Therapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2013-003664-32-NL
- Lead Sponsor
- Medical Center Alkmaar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
•Patients (male or female) undergoing elective laparoscopic surgery for colon cancer
•Age between 60 and 80 years
•BMI between 20 kg/m2 and below 30 kg/m2
•Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 32
•Participation in or having participated in another clinical trial within the previous 3 months
•Indications for continuously use of anticoagulant medication and no possibility to stop these medication perioperatively, for example patients with an artificial heart valve
•Bleeding disorders, determined by medical history and laboratory tests of clotting indices
•Metastatic disease
•Recent cardiac or cerebral infarction within the last 6 months
•Current history of inflammatory or infectious disease
•The use of anti-inflammatory drugs
•The use of thyroid medication
•The use of fish oil products or fish consumption more than 2 times a week
•Contra-indications for the use of Omegaven-Fresenius
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method